DOMINION VETERINARY LABORATORIES LTD.
Form 483 issued September 21, 2023 · WINNIPEG, Canada
- Observations
- 5
- Pages
- 4
- FEI number
- 3004103905
In short: On September 21, 2023, FDA issued a Form 483 with 5 observations to DOMINION VETERINARY LABORATORIES LTD. in WINNIPEG, Manitoba (FEI 3004103905). Most observations concern materials and laboratory controls.
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 02
Each batch of drug product required to be free of microorganisms is not tested…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Repeat Observation The in-process control procedures were deficient in that they did not include an examination…
This inspection in context
Questions about this 483
What did FDA find at DOMINION VETERINARY LABORATORIES LTD.?
FDA listed 5 observations on this Form 483, mostly about materials, laboratory controls and quality system. The opening words of each observation are shown on this page.
When was DOMINION VETERINARY LABORATORIES LTD. inspected by FDA?
This Form 483 is dated September 21, 2023.
How do I get the full Form 483 for DOMINION VETERINARY LABORATORIES LTD.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.